Patients With Distal Radius Fracture

NCT04071002 | Completed

• 1 other identifier: 3518
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Surgically and conservatively treated distal radius fractures followed for six month. In this period 12 weeks rehabilitation programme applied for each group. Nine different evaluations were done in the initial, after physical therapy and 6th month. Results were presented.

Conditions

Physical Disability

Keywords

Distal radius fracture; functional status; activity participation; hand therapy

Outcome Measures

Primary Outcomes (9)

• Visual Analogue Scale

  To evaluate pain severity, patient show a point to indicate her/his pain between 0-10 points on a vertical 100mm line. Severity of pain was assessed with VAS in sleep, rest, and activity.

  six month

• algometer

  An algometer is used to evaluate pain threshold of the patient for distal radioulnar joint, ulnas styloid, m.pronator quadratus, radial styloid, m. flexor pollicis longus, and triangular fibrocartilage complex.The threshold value of pain was recorded by placing the probe against the points. Then, it was gradually increased and reduced to apply a pressure of 1kg / 0.5cm² with 0.5 cm² probe head .

  six month

• range of motion

  An universal goniometer is used to evaluate patient's active motion of joints for wrist and forearm.

  six month

• grip strength

  Grip strength was measured by a hand dynamometer according to the American Association of Hand Therapy Association's standard grip strength measurement method. Right/left extremity and their progression are compared in this evaluation.

  six month

• radiographic evaluations

  The posteroanterior (PA) and lateral (L) radiographic measurements were assessed by an experienced hand surgeon to determine the type of fracture, geometry, and associated pathology. Radial length and radial inclination were assessed by PA radiography. Dorsal or volar angulations of the distal fragment were evaluated on the lateral radiography.

  six month

• Push-Off Test (POT)

  POT was performed to determine the weight transfer strength of the patient to the injured extremity. The test was performed simultaneously and bilaterally by reversing the hand parts of the two hand dynamometers.

  six month

• Michigan Hand Outcomes Questionnaire (MHOQ)

  MHOQ was used for evaluating the participation and functional levels of the patients. In the questionnaire consisting of 37 questions under six headings, general hand function, daily life activities, pain, work, aesthetics and satisfaction are evaluated. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.

  six month

• Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH)

  It was used to assess the upper extremity functional status of patients from their perspective. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. It includes 11 item. The score on test ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity.

  six month

• Jebsen-Taylor Hand Function Test (JTHFT)

  The seven individual subtests of JTHFT writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects, were performed as a standardized procedure.

  six month

Study Arms (2)

surgical group

ACTIVE COMPARATOR

distal radius fractures that treated volar plate

Other: 12 weeks physical therapy programme

conservative group

ACTIVE COMPARATOR

distal radius fractures that treated plaster of paris

Other: 12 weeks physical therapy programme

Interventions

12 weeks physical therapy programme OTHER

The programme include contrast bath, bandage, massage, active exercises, resistive exercises.

conservative group; surgical group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 60
• Diagnosed with distal radius fracture
• Primary fixation after injury.

You may not qualify if:

• Bilateral distal radius fracture
• Concomitant ulna styloid fracture
• Another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb
• Patients who underwent surgery that involved ipsilateral upper extremity
• Associated injuries such as nerve or tendon injuries
• Secondary procedures at follow-up
• Un-cooperated patients.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Kinikli, 20000, Turkey (Türkiye)

Location

Related Publications (1)

• Valdes K, Naughton N, Michlovitz S. Therapist supervised clinic-based therapy versus instruction in a home program following distal radius fracture: a systematic review. J Hand Ther. 2014 Jul-Sep;27(3):165-73; quiz 174. doi: 10.1016/j.jht.2013.12.010. Epub 2014 Jan 3.

  PMID: 24508093 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• HANDE USTA, MSC

  Pamukkale University

  PRINCIPAL INVESTIGATOR

• ALI KITIS, PROF

  Pamukkale University

  STUDY CHAIR

• AHMET FAHIR DEMIRKAN, PROF

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Assistant

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: January 21, 2015
• Primary Completion: June 9, 2016
• Study Completion: September 1, 2016
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)